Brief Summary
This study aims to find out:
- The tolerability of Cabotamig (ARB202) in adults with advancedat a late stage, far along solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.
- To find out how study drug is broken down in the body
- To know the effects of the study drug on the tumor.
Intervention / Treatment
- Drug: Cabotamig (ARB202)
Inclusion Criteria
- Histologically confirmed colorectal, pancreatic, gastric adenocarcinomacancer arising from mucus-producing glands in organs, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy > 3 months.
- Measurable disease as defined by RECIST 1.1 criteria
- Blood coagulation parameters:
- PT INR ≤ 1.5X ULN
- PTT INR ≤1.2X ULN
- Patients must have adequate venous peripheral access for apheresisa medical procedure where a machine separates a particular blood compnent from the blood and then returns the rest to the body.
- Satisfactory organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function as defined by:
- absolute neutrophil count > 1,000/μL
- platelets >100,000/μL
- hemoglobin ≥9 g/dL
- serum ALT and AST ≤ 3X ULN or AST and ALT ≤5X ULN, if liver function abnormalities are thought to be from underlying malignancy
- total serum bilirubin ≤ 2X ULN
- Creatinine <1.5X ULN
- Stable amylase for 2 weeks